The National Institutes of Health (NIH) wants to let the sun shine on researchers' financial interests. The nation's biggest funder of biomedical research has proposed several changes to its rules governing when and how investigators should disclose financial interests from industry. By requiring greater disclosure of researchers' stock holdings, consulting fees and other monetary interests, the rewrite is designed to strengthen oversight while tamping down on financial conflicts of interest (FCOI).
A year in the making, the 25-page proposal appears in last Friday's Federal Register. Much of the new language concerns what kinds of financial interest are subject to disclosure, spelling out whose responsibility it is to report these and to whom they must be disclosed, as well as how to manage FCOIs when they occur.
However, the NIH does not offer to take on responsibility for collecting this information, as some have suggested it should, instead calling for universities to shoulder this burden.
In a JAMA commentary, also released on Friday, NIH director Francis Collins and Sally Rockey, NIH acting deputy director for extramural research, call attention to three main differences between the draft rule and the agency's current regulation, which dates back to 1995:
• Proposed rule: Requires NIH-funded investigators to disclose to their institutions all significant financial interests related to their institutional responsibilities. “This would move the responsibility for determining if an investigator's significant financial interests are related to NIH-supported research from the investigator to his or her institution,” Collins and Rockey noted. The draft rule would also lower the monetary threshold at which interests require disclosure generally to $5,000.
• Current rule: Investigators determine and disclose to institutions any significant financial interest that would reasonably appear to be affected by the NIH-supported research, as well as any significant financial interest involving entities whose financial interests would reasonably appear to be affected by the research; minimum threshold $10,000.
• Proposed rule: Requires institutions to develop a management plan for every identified FCOI, which may include reduction or elimination of the FCOI.
• Current rule: Manner of compliance not specified
• Proposed rule: Requires every NIH-funded institution to post, on a publicly accessible website, information on certain significant financial interests that the institution has determined are related to NIH-funded research and constitute FCOI.
• Current rule: No public notice
Collins anticipates that shifting the onus to institutions could result in “more consistent identification, evaluation, and management of any identified conflicts.” It would also parallel current practices at many institutions, which require investigators to disclose interests annually and/or on an ongoing basis.
However, NIH has drawn past scrutiny for relying too much on universities to police this process. In a 2008 report, the Office of Inspector General (OIG) criticized NIH for relying primarily on grantee institutions' assurances that FCOI rules are followed. At the time, OIG called on NIH to take a more active role in overseeing FCOI among grantee institutions by collecting details on the nature and management of such conflicts. NIH responded that collecting such details is the university's legal responsibility.
As to what types of financial interests should raise a red flag, the new draft rule says interests that must be reported should only be those that “reasonably appear to be related to the investigator's institutional duties.” Collins thinks this criteria would result in the reporting of a “wider array of interests on a more frequent basis,” he wrote in the Federal Register.
Comments to the proposed rewrite must be received on or before July 20, and NIH is expected to issue final rules by year's end.
NIH-funded research is one of several areas where a push is on to tighten oversight of conflicts. In recent years, increased interaction among government, research institutions and the private sector has prompted new conflict rules for panelists who serve on FDA advisory committees and for med school faculty involved in giving CME talks. And the Physician Payments Sunshine Act, included in the 2010 healthcare reform legislation, requires drug and device firms to report payments to physicians.